HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 

Medical Policy:
G-25-038
Topic:
Intra-Articular Hyaluronan Injections for Osteoarthritis of the Knee
Section:
Miscellaneous
Effective Date:
June 1, 2018
Issued Date:
October 1, 2018
Last Revision Date:
October 2018
Annual Review:
December 2017
 
 

Intra-articular injections of hyaluronan act as lubricants to restore elasticity and viscosity to the arthritic knee. The procedure involves an arthrocentesis to aspirate the damaged synovial fluid from the knee. Then, to replace the fluid, the hyaluronan preparation is injected.

Policy Position Coverage is subject to the specific terms of the member's benefit plan.

The following FDA approved hyaluronan preparations are the preferred injections:

Euflexxa® (1% sodium hyaluronate), Durolane® (hyaluronic acid), Supartz™ (sodium hyaluronate), and GelSyn-3™ (hyaluronic acid)
Intra-articular hyaluronan injections may be considered medically necessary when ALL of the following are met:

  • The patient has documentation of diagnosis of symptomatic painful osteoarthritis of the knee and there is no evidence of inflammatory arthritis (e.g., rheumatoid arthritis); and
  • There is documentation of failure to respond adequately to at least three (3) months of conservative* therapy; and
  • There are no contraindications to the hyaluronan injections; and
  • There is documentation that the pain interferes with functional activities (e.g., ambulation, prolonged standing); and
  • Cause of pain cannot be attributed to other forms of joint disease; and
  • The injections are performed by a licensed medical professional (e.g., MD, DO, PA or CRNP). Injections cannot be performed by nursing or other medical personnel.

*Conservative therapy includes the following:

  • Activity modification, participation in a home exercise program implemented by a physical therapist, protective weight bearing; and
  • Non-narcotic analgesics (e.g., acetaminophen, NSAIDS) 1 gram up to four (4) times daily, topical anti-inflammatory preparations including capsaicin cream applied to affected knee joint, and
  • Intra-articular corticosteroid injections; or                                            
  • The individual is unable to tolerate conservative therapy because of adverse side effects or other medical condition.

Arthrocentesis and the injection of hyaluronic acid derivatives for all other body joints is considered not medically necessary.

20610

J7323

J3490

J7321

J7328

 

 



C9465

 

 

 

 

 

 




FDA approved Non-Preferred Injections (Hyalgan® (sodium hyaluronate), Orthovisc® (high molecular weight hyaluronan), Gel One® (cross-linked hyaluronate), Monovisc® (lightly cross-linked high molecular weight hyaluronic acid), GenVisc 850® (sodium hyaluronate), Synvisc® (hylan G-F 20), Synvisc-One® (hylan G-F 20), and Hymovis® (high molecular weight viscoelastic hyaluronan))
Non-preferred Intra-articular hyaluronan injections may be considered medically necessary when BOTH of the following are met:

  • The member has met ALL the clinical criteria requirements as stated above for the preferred injections; and
  • The member must have had an adequate* therapeutic trial and experienced a documented drug therapy failure** with all applicable preferred intra-articular hyaluronan products.

*An adequate therapeutic trial consists of using a preferred product at recommended doses for a period of time adequate to assess therapeutic benefit (unless the patient experiences an intolerable adverse effect due to drug therapy within that time period).  

**Drug therapy failure consists of not achieving the desired therapeutic goal, development of an intolerable adverse effect due to drug therapy, or development of a hypersensitivity reaction to the drug product. The length of therapy with the preferred product(s) and the reason(s) for drug therapy failure should be documented.

Non-Preferred Injections (Hyalgan® (sodium hyaluronate), Orthovisc® (high molecular weight hyaluronan, Gel One® (cross-linked hyaluronate), Hymovis® (high molecular weight viscoelastic hyaluronan), GenVisc 850® (sodium hyaluronate), Synvisc® (hylan G-F 20), Synvisc-One® (hylan G-F 20), and Monovisc® (lightly cross-linked high molecular weight hyaluronic acid)) are considered not medically necessary if the above criteria is not met.

20610

J3490

J7320

J7321

J7322

J7324

J7325

J7326

J7327

J7328

 

 

 

 




Repeat Treatment Cycles
An additional course of the previously approved viscosupplementation therapy may be considered medically necessary for treatment of painful osteoarthritis of the knee when ALL of the following are met:

  • At least six (6) months must have elapsed since the previous injection or completion of  the prior series of injections; and
  • The patient and provider have elected to continue conservative/non-surgical management of the osteoarthritis (no surgery planned within six (6) months of viscosupplementation therapy); and
  • The medical record must objectively document significant improvement in pain and functional capacity of the knee joint. (e.g., an improvement in an objective measurement of pain and/or functional status Visual Analog Scale [VAS], Western Ontario and McMaster Universities Osteoarthritis [WOMAC] Index, or other validated objective measure).

Repeat treatment cycles of Intra-Articular Hyaluronan injections are considered not medically necessary if the above criteria are not met.

20610

J7321

J7323

J7324

J7325

J7327

J7328

J3490

 

 

 

 

 

 




Imaging guidance is considered not medically necessary when performed during intra-articular hyaluronan injections for osteoarthritis of the knee.

20611

76942

 

 

 

 

 




The following hyaluronan products are FDA-approved for intra-articular injections of the knee: 

  • Euflexxa®  (1% sodium hyaluronate)
  • Durolane® (hyaluronic acid)
  • GelSyn-3™ (hyaluronic acid)
  • Supartz®   (sodium hyaluronate)
  • Hyalgan®  (sodium hyaluronate)
  • Synvisc®   (hylan G-F 20)
  • Synvisc-One™(hylan G-F 20)
  • Orthovisc® (high-molecular-weight hyaluronan)
  • Gel-One®  (hyaluronic acid)
  • Monovisc® (lightly cross-linked high molecular weight hyaluronic acid)
  • GenVisc 850® (sodium hyaluronate)
  • Hymovis® (high molecular weight viscoelastic hyaluronan)

Dosage recommendations per the FDA label.


Related Policies

Do not apply Medical Policy Bulletin S-31 guidelines to intra-articular hyaluronan injections. 

Refer to Pharmacy Policy J-501 for additional information.


Covered Diagnosis Codes for J7320, J7321, J7322, J7324, J7325, J7326, J7327, J7328

M17.0

M17.2

M17.4

M17.5

M17.9

M17.10

M17.11

M17.12

M17.30

M17.31

M17.32

 

 

 



Place of Service: Outpatient

The administration of Intra-Articular Hyaluronan injections for osteoarthritis of the knee is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.


The policy position applies to all commercial lines of business


Denial Statements

Services that do not meet the criteria of this policy will not be considered medically necessary. A network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.



Links






This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.

Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
  • If you need these services, contact the Civil Rights Coordinator.

    If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

    You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

    U.S. Department of Health and Human Services
    200 Independence Avenue, SW
    Room 509F, HHH Building
    Washington, D.C. 20201
    1-800-368-1019, 800-537-7697 (TDD)

    Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

    Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans.